Traumatone Liquid
FDA Label NDC 44911-0714

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Traumatone (NDC 44911-0714). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, purpose:, warnings:, keep out of reach of children:, directions:, indications:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

(in each drop): 7.68% of Arnica Montana 12X, Bellis Perennis 12X, Camphora 12X, Hamamelis Virginiana 12X, Hypericum Perforatum 12X, Ledum Palustre 12X, Natrum Sulphuricum 12X, Phosphorus 12X, Rhus Tox 12X, Ruta Graveolens 12X, Staphysagria 12X, Strontium Carbonicum 12X, Symphytum Officinale 6X; 0.10% of Calendula Officinalis 3X.

Purpose:

May temporarily relieve soreness after exertion, bruises, strains, sprains, and joint pain and stiffness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

Keep Out Of Reach Of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve soreness after exertion, bruises, strains, sprains, and joint pain and stiffness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Questions:

Dist. by Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579

800.869.8078

Package Label Display:

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
TRAUMATONE
1 fl. oz. (30 ml)

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